NCT07220629

Study to Explore the Safety and Efficacy of NT-0796 as an Adjunct to Semaglutide in Participants With Obesity (RESOLVE-2)

A Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Explore the Safety and Efficacy of NT-0796 as an Adjunct to Semaglutide Plus a Reduced Calorie Diet and Increased Physical Activity in Participants With Obesity

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: NodThera Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Phase 2a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to explore the safety and efficacy of NT-0796 as an adjunct to semaglutide in participants with obesity over a 6 months treatment period.

Detailed description

Potential participants will be screened within 28 days prior to baseline (Day 1), and eligible participants will be randomly assigned to receive the Investigational Medicinal Product (IMP, either NT-0796 or placebo) twice daily (BID). All participants will receive sc semaglutide. The IMP will be administered orally. Semaglutide will be initiated and titrated using a fixed, 4-weekly dose escalation scheme, as per the approved USPI. Following 32 weeks of active treatment, participants will enter a 4-week safety follow-up period before being discharged from the study. Semaglutide will be provided for the period from baseline (Day 1) up until completion of the 4-week safety follow-up. The Primary Endpoint of the study will be the safety and tolerability of NT-0796 as an adjunct to semaglutide, the key secondary endpoint will be the effect of NT-0796 as an adjunct to semaglutide on weight loss while secondary endpoints include percentage weight change from baseline.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	NT-0796	Orally administered capsules
DRUG	Placebo	Orally administered capsules

Timeline

• Start date: 2025-10-02
• Primary completion: 2026-08-21
• Completion: 2026-08-21
• First posted: 2025-10-24
• Last updated: 2026-04-08

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study